Eisai has filed for approval in Japan for tasurgratinib, its small-molecule fibroblast growth factor (FGF) receptor inhibitor, as a treatment for biliary tract cancers with FGFR2 gene fusion mutations.

卫材已在日本申请批准其小分子成纤维细胞生长因子（FGF）受体抑制剂tasurgratinib用于治疗具有FGFR2基因融合突变的胆道癌。

The application to the Ministry of Health, Labour and Welfare (MHLW) is set for a priority review, reflecting the relatively high incidence of biliary tract cancer in Japan relative to other countries and the poor prognosis for patients with this type of cancer, also known as cholangiocarcinoma.

向日本厚生劳动省（MHLW）提交的申请将进行优先审查，这反映出日本胆道癌的发病率相对于其他国家相对较高，并且这种癌症（也称为胆管癌）患者的预后较差。

Tasurgratinib (also known as E-7090) is an oral selective FGFR1, FGFR2, and FGFR3 inhibitor that if approved will join other drugs in the class on the market including Incyte’s Pemazyre (pemigatinib), Taiho Oncology’s Lytgobi (futibatinib) and Johnson & Johnson’s Balversa (erdafitinib).

Tasurgratinib（也称为E-7090）是一种口服选择性FGFR1，FGFR2和FGFR3抑制剂，如果获得批准，将与市场上的其他药物一起使用，包括Incyte的Pemazyre（pemigatinib），Taiho Oncology的Lytgobi（futibatinib）和Johnson＆Johnson的Balversa（erdafitinib）。

Eisai’s drug has been submitted for approval on the back of a single-arm phase 2 trial (Study 201) which enrolled patients in Japan and China with FGFR2 gene fusion-positive unresectable biliary tract cancer that had previously been treated with gemcitabine-based combination chemotherapy – the standard first-line treatment..

卫材的药物已在单臂2期临床试验（研究201）的基础上提交批准，该试验招募了日本和中国FGFR2基因融合阳性不可切除胆道癌患者，这些患者先前曾接受吉西他滨联合化疗（标准一线治疗）治疗。。

FGFR1-targeting Pemazyre was approved by the FDA for previously treated biliary tract tumours with FGFR2 gene fusions in 2020, becoming the first targeted therapy for the disease, and last year had its label extended to include patients with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement..

以FGFR1为靶点的培马泽于2020年被FDA批准用于先前治疗的FGFR2基因融合的胆道肿瘤，成为该疾病的第一种靶向治疗方法，去年其标签扩展到包括复发或难治性骨髓/淋巴肿瘤（MLNs）患者FGFR1重排。。

It was joined by Lytgobi last year, an FGFR2 inhibitor cleared by the FDA as a second-line therapy for cholangiocarcinoma with FGFR2 gene fusions or other rearrangements. At the moment, FGFR2 and FGFR3 inhibitor Balversa is only FDA-approved for bladder cancer.

Lytgobi去年加入了该研究，Lytgobi是一种FGFR2抑制剂，被FDA批准作为FGFR2基因融合或其他重排的胆管癌的二线治疗药物。目前，FGFR2和FGFR3抑制剂Balversa是FDA唯一批准用于膀胱癌的药物。

Around 25,000 people in Japan are diagnosed with biliary tract cancer, with a five-year survival rate of just 25%. It is the sixth-leading cause of cancer-related deaths for women and the seventh-leading cause of cancer-related death for men in the country.

日本约有25000人被诊断出患有胆道癌，五年生存率仅为25%。它是该国女性癌症相关死亡的第六大原因，也是男性癌症相关死亡的第七大原因。

FGFR2 gene fusion is observed in approximately 14% of intrahepatic cholangiocarcinoma, which accounts for 15%-30% of all biliary tract cancers, according to Eisai, but drug options are limited.

据Eisai称，在大约14%的肝内胆管癌中观察到FGFR2基因融合，占所有胆道癌的15%〜30%，但药物选择有限。

It is a rare tumour and, for now, Eisai does not appear to have any aspirations to develop tasurgratinib outside Asia, possibly because it would be a late entrant. It is playing catch-up in Japan too, however, as Pemazyre got MHLW approval there in March.

这是一种罕见的肿瘤，目前，卫材似乎没有任何愿望在亚洲以外开发tasurgratinib，可能是因为它进入较晚。然而，它在日本也在迎头赶上，因为Pemazyre在3月份获得了MHLW的批准。

Meanwhile, AstraZeneca recently got approval in Japan for its cancer immunotherapy combination of PD-L1 inhibitor Imfinzi (durvalumab) and CTLA4 inhibitor Imjudo (tremelimumab) as a first-line therapy for cholangiocarcin9oma in combination with chemotherapy.

与此同时，阿斯利康最近在日本获得批准，将PD-L1抑制剂Imfinzi（durvalumab）和CTLA4抑制剂Imjudo（tremelimumab）的癌症免疫治疗组合作为胆管癌联合化疗的一线治疗。

Eisai is also developing tasurgratinib for breast cancer and is currently running a phase 1 trial in this indication.

卫材还正在开发用于乳腺癌的tasurgratinib，目前正在进行该适应症的1期临床试验。